Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXThe majority of States now have an adequate supply of H1N1 vaccine to offer to anyone desiring protection from the novel H1N1 influenza virus. Supply is also increasing rapidly in DoD as facilities receive vaccine more often and in larger quantities. January 2010 is shaping up to be a busy month with respects to administering the H1N1 vaccine to uniformed service members and other DoD beneficiaries.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXOver 80 million doses of H1N1 vaccine have been distributed in the United States with no increases in adverse events compared to previous year’s seasonal influenza vaccine. This holds true for the DoD also, where over a million doses have been administered to uniformed personnel, dependants, and retirees with no increase in adverse events noted when compared to the seasonal influenza vaccine.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXH1N1 vaccine manufacturer MedImmune has recalled 13 lots of intranasal vaccine. This recall is due to lower than required potency levels. Vaccine potency had decreased below the pre-specified limit or was at risk of falling below that limit in the near future. The vaccine was within the specified range at the time of distribution. Approximately 4.7 million doses of this vaccine, which is recommended for individuals 2 to 49 years old, were distributed throughout the United States during October and November 2009. Individuals who received this vaccine do not require re-vaccination, as the potency is not significantly below the specified range, and is still expected to stimulate a protective immune response. DoD Med/Log released a Medical Materiel Quality Control message on 23 December to inform Department of Defense logisticians and clinicians as to the specific lots affected and the proper disposition instructions when returning un-used vaccine to the manufacturer. This is not a safety recall.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXH1N1 vaccine manufacturer Sanofi Pasteur has recalled eight lots of pediatric vaccine. This recall is due to lower than required potency levels. Vaccine indicated for children aged six to 35 months old was found to be slightly below pre-specified limits. Approximately 800K doses of this vaccine were distributed throughout the United States during November 2009. Children who received this vaccine do not require re-vaccination, as the potency is not significantly below the specified range, and is still expected to stimulate a protective immune response. This is not a safety recall. Remember, children ages 6 months to 10 years require two doses of the H1N1 vaccine spaced at least a month apart in order to be considered fully protected.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXThe Acting Deputy Assistant Secretary of Defense, Forces Health Protection and Readiness made it a little easier. His 30 Oct 09 policy memo states that ‘regardless of the vaccine source or intended population category, available vaccine should be provided to any beneficiary who has a medical condition placing them at a higher risk for influenza-related complications. This does not pertain to age-based target groups but does include those conditions described in the CDC’s: Use of Influenza A (H1N1) 2009 Monovalent Vaccine.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXThe TRICARE Management Activity (TMA) has temporarily lifted the requirement that TRICARE Prime enrollees obtain a referral from their primary care manager (PCM) to receive H1N1 vaccination from a non-network, TRICARE-authorized provider. This means Prime enrolled active duty, dependents, and retirees can be vaccinated by any TRICARE-authorized provider having the vaccine in stock. The immunization comes without any point-of-service charges to the beneficiaries. TMA’s goal is to reduce any obstacles that TRICARE Prime enrollees may encounter in obtaining the H1N1 vaccine. The TRICARE regulation’s PCM requirement is temporarily suspended until 30 April 2010 and includes OCONUS beneficiaries.

The DHHS will allocate 1 million doses of Sanofi-Pasteur’s injectable multi-dose inactivated H1N1 vaccine (indicated for ages 6 months and up) for DoD to distribute using its own medical logistics infrastructure. The Defense Logistics Agency (DLA) will receive this vaccine into its depot system and ship according to OSD(HA) and Service priorities. This vaccine is intended for DoD’s non-beneficiary workforce and OCONUS DoD beneficiaries. Vaccine is scheduled to begin arriving at the DLA depot mid-October and continue until a total of one million doses is allotted.

This vaccine, in the amount of 2.7 Million doses for use by DoD Uniformed Service Members, will consist of Novartis injectable multi-dose inactivated vaccine indicated for ages 4 years and up. This vaccine is being released on a timeline comparable to the other injectable inactivated products. Small amounts of vaccine (in the hundred thousand dose range) are scheduled for release the end of October, but large amounts will not be available until early November.

Please remember that priority for intitial doses are deployed and deploying troops, and other high-risk Service Members.

This is the main distribution system for the US, and is seen by the DHHS as being vital to the Federal Government’s ability to respond to future pandemics that may have a more deadly presentation. The allocation of vaccine is based on the population of each state. Each state hosts a website where medical providers register to become immunizers. DoD military treatment facilities (MTFs) must participate in this system in order to receive vaccine for their non-uniformed beneficiaries. Vaccine distributed through this route consists of all five manufacturer’s products.

Presently, MedImmune’s intranasal product is being distributed to the states. This is due to a faster manufacturing process which consistently allows MedImmune to market its product before other manufacturers. Vaccine received by MTFs through this system is intended for DoD’s non-uniformed beneficiaries.

The Department of Health and Human Services (DHHS) was directed by the President of the United States to contract with manufacturers to produce enough H1N1 vaccine for those who wish to be immunized. DHHS has estimated there will eventually be close to 250 million doses available. This amount will be a mixture of products from Sanofi-Pasteur, Novartis Vaccines and Diagnostics Limited, CSL Limited, GlaxoSmithKline, and MedImmune LLC.

DoD will receive vaccine from DHHS, from 3 different pools or allotments:

State Distribution - (coordinated locally)

DoD Uniformed Service Members - (2.7 million doses)

Federal Govenrment and OCONUS Beneficiaries - (1 million doses)

Please note that vaccine should be used according to the different target groups and allotments.

The Live Inactivated Influenza Vaccine (LAIV) is administered intranasally. There is both a seasonal and novel H1N1 LAIV product. The following are various scenarios in which the intranasal vaccine can be administered:

Intranasal Vaccine may be given with any inactivated vaccine without regard to timing per Centers for Disease Control and Prevention (CDC) national recommendations.

Intranasal Vaccine may be administered on the same day as injectable live virus vaccines. If this is not possible, then the vaccinations should be separated by at least 28 days, according to CDC recommendations.

Two LAIVs, e.g., seasonal and novel H1N1 intranasal vaccine, should not be administered in near concurrent fashion due to theoretical concerns of viral re-assortment which could lead to a diminished immune response to both vaccines, according to CDC recommendations. If two LAIV’s are mistakenly administered concurrently there is no need to revaccinate.

ArchivedFor uniformed personnel the answer is -- yes the H1N1 vaccination is still recommended.

Persons should be vaccinated regardless of having a lab confirmed 2009 H1N1 virus infection. Most people ill with an influenza-like illness (ILI) since this spring have not had testing with the RT-PCR test, which is the only test that can confirm infection specifically with the 2009 H1N1 virus. Tests such as rapid antigen detection assays, and diagnoses based on symptoms alone without RT-PCR testing, cannot specifically determine if a person has 2009 H1N1 influenza. Persons who were not tested, but who became ill after being exposed to a person with lab confirmed 2009 H1N1 influenza should not assume that they also had 2009 H1N1 since many pathogens can cause an ILI, and should get the vaccine.

Someone who was infected with the 2009 H1N1 virus and who is not severely immune compromised will likely have some immunity to subsequent infection with 2009 H1N1 virus. However, vaccination of a person with some existing immunity to the 2009 H1N1 virus will not be harmful and persons who are uncertain about how they were diagnosed should get the 2009 H1N1 vaccine. Additionally, persons recommended for seasonal vaccine should get a seasonal vaccine because infection with the 2009 H1N1 virus does not provide protection against seasonal influenza viruses.

H1N1 vaccine is expected to be released in the October to November timeframe. It may be available in early October.

There will be two different sources of vaccine for DoD Immunizers:

For DoD operational requirements vaccine will be distributed per the normal seasonal influenza vaccine model.

For non-operational requirements which includes dependents, retirees and anyone else who is enrolled for care at a military treatment facility that is not a part of the DoD mission.

To obtain vaccine for the non-operational component of the DoD population, each military treatment facility that normally provides seasonal influenza vaccine must register with the State as a vaccine provider. The facility and not each provider registers. Registration is with each State in which your enrolled population resides.

Archived The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA has contracted with manufacturers that currently hold U.S. licenses for flu vaccine. The H1N1 vaccine procured by these contracts will be stockpiled in the CDC’s Strategic National Stockpile (SNS). The SNS will then arrange for its delivery to the States in amounts based on each State’s population. The DoD has purchased an amount of vaccine from DHHS for it’s operational forces and will also receive various allotments from the DHHS based on additional DoD needs. Vaccine will also be available to DoD beneficiaries through State allocations. Regardless of the source of H1N1 vaccine the cost is centrally funded either from DoD or DHHS and will not be passed on to organizations that immunize.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXThe ACIP, a panel made up of medical and public health experts, met 29 July 09, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXTwo regulatory options exist for H1N1 vaccines; 1) Licensure: an H1N1 vaccine manufactured using the same process as the U.S. licensed inactivated influenza vaccine, or seasonal live attenuated influenza vaccine will be licensed for use in the U.S., or 2) Emergency Use Authorization (EUA): Currently, no U.S licensed vaccine contains the adjuvants MF-59 or ASO3. It is expected that an H1N1 vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only. Products by statute, that are eligible for emergency use are those that “may be effective” in preventing serious or life threatening disease. If enough doses of licensed unadjuvanted vaccine can be secured and the H1N1 virus pandemic remains mild the use of a licensed product would be preferred over the use of a vaccine under an EUA.

Archived Author: LTC Patrick Garman, PhD, Deputy Director, MILVAXThe CDC reported the level of cross reactive antibody to the novel influenza A(H1N1) virus in stored and pre- and post vaccination sera from 359 U.S. children and adults vaccinated with seasonal influenza vaccines from 2005 to 2009 (MMWR 2009;58:521-524). The results suggest that while older persons may have some level of pre-existing immunity to the novel H1N1 strain, children and younger adults have no or low levels of serum antibody, respectively, that are cross reactive to the novel influenza A(H1N1) virus. Translation: Because most people have little or no pre-existing immunity to the novel influenza A(H1N1) virus there may be a need for a two dose regimen as a single dose of monovalent novel influenza A(H1N1) vaccine may not provide an adequately protective immune response.